AbbVie (ABBV) Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C

CHICAGO – The hepatitis C market just got more crowded after the U.S. Food and Drug Administration (FDA)approvedAbbVie (ABBV)’s Mavyret, a drug that will treat all types of HCV in an eight week timeframe.

With the approval, AbbVie has rival HCV drugmaker Gilead Sciences (GILD) squarely in its sights. AbbVie estimates that approximately 95 percent of U.S. HCV patients can be treated with Mavyret, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD.

AbbVie Chief Scientific Officer Michael Severino said the approval of Mavyret means patients and physicians have an option that cuts treatment for HCV to eight weeks, down from the 12 week regimen of Gilead’s top drugs, Sovaldi and Harvoni.

According to the FDA, Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The approval of Mavyret was supported by data from nine across all major HCV genotypes (GT1-6) and special populations. Mavyret (glecaprevir/pibrentasvir) is a once-daily, ribavirin-free treatment for adults with chronic HCV. Mavyret combines two new direct-acting antiviral treatments that target and inhibit proteins essential for the replication of the hepatitis C virus.

Trial data demonstrated that 92 to 100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured, the FDA said in its announcement. The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.

There are an estimated 3.4 million people in the United States diagnosed with chronic HCV.

Sales of Mavyret are pegged at about $1.3 billion by 2022, EvaluatePharma said, as reported by Endpoints News. However, Gilead dominates the HCV market and does so for a reason. For AbbVie to carve out a blockbuster share of the HCV space, it will have to be aggressive. But, the eight week regimen may make this drug more appealing, Leerink analyst Geoffrey Porges said in note to investors.

“Patients, physicians and payers are likely to embrace Mavyret given the drug’s profile and excellent clinical data, and this approval and the subsequent market share encroachment are a key part of our cautious stance towards Gilead’s stock. Conversely, for AbbVie, this pricing means that the revenue contribution from Mavyret is likely to be limited, and largely consistent with our existing forecast,” Porges said, as cited by Endpoints.

Another factor that could play into AbbVie’s favor is the estimated price of Mavyret. Evercore ISI’s Umer Raffat provided figures to Endpoints that shows AbbVie will market Mavyret at a significantly lower price than the other HCV drugs on the market. The wholesale price of Mavyret for a four-week period is pegged at $13,200. The closest is
Merck (MRK)’s Zepatier at $18,200. Harvoni is the highest at $31.500 for the same time period.

Shares of AbbVie are down slightly this morning, trading at $70.54 as of 10:41 a.m. Shares of Gilead Sciences are also down, trading at $73.01 as of the same time.